Acorda Therapeutics has presented data from a PK study of its diazepam nasal spray showing that dosing during seizure produces comparable pharmacokinetics to dosing immediately following a seizure. The company recently submitted an NDA for intranasal diazepam for the treatment of epilepsy and has said that it expects to market the product as early as 2014 if it is approved.
The data presented at the annual meeting of the American Epilepsy Society came from a multicenter, open-label study involving 30 adult epilepsy patients. Ten of the patients received a dose of intranasal diazepam during seizure. The study looked at plasma concentrations for those patients and for those who received a dose after a seizure for up to 12 hours post-dose.
Acorda Senior VP of Clinical Development and Medical Affairs Adrian Rabinowicz said, “In this study, some patients received a dose of diazepam nasal spray while having a seizure, while others received the dose after their seizure activity had ceased. The results suggest that delivery of diazepam nasal spray was unaffected by the timing of dosage relative to seizure activity. It is critical for a person with epilepsy who experiences cluster seizures that treatment be administered as soon as possible after a cluster is recognized, in order to prevent additional seizure activity.”
Read the Acorda press release.
